COVID19 - Curosurf_ARDS_COV19 [COVID-19]
Research type
Research Study
Full title
Multicenter, open-label, randomised trial to assess the efficacy and tolerability of poractant alfa (porcine surfactant, Curosurf®) in hospitalized patients with SARS-COV-19 acute respiratory distress syndrome (ARDS)
IRAS ID
283660
Contact name
Stefania Pirondi
Contact email
Sponsor organisation
CHIESI FARMACEUTICI S.p.A
Eudract number
2020-002632-75
Duration of Study in the UK
0 years, 10 months, 9 days
Research summary
The aim of the study is, primarily, to evaluate the efficacy of pulmonary surfactant (porcine surfactant, Curosurf®), administered by endotracheal (ET) instillation in terms of ventilatory free days in adult patients with ARDS (acute respiratory distress syndrome) due to 2019-nCoV infection.
Furthermore, it wants to investigate possible mechanism that could impact on surfactant functionality in COVID-19 infected patients requiring ventilator support (as exploratory objective).
Curosurf® is currently marketed as treatment of premature neonates with RDS (respiratory distress syndrome); ARDS has clinical and pathophysiological similarities with neonatal RDS, which is due to an alveolar collapse due to surfactant-deficiency for immaturity of the alveolar type II epithelial cells of the lungs.
The study will be conducted in approximately 7 Intensive Care Units (ICU) in England and includes a group of adult patients treated with Curosurf® (approximately 42) and a control group (approximately 28)on standard of care who will be randomly assigned to one of the two groups. An additional cohort of same patients, supported by extracorporeal membrane oxygenation (ECMO-cohort) will be randomised (9 patients in the poractant alfa treatment and 6 patients in the control one) in 3 out of 7 centres involved in the study. Each patient will remain in the study 28 days.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
20/SC/0258
Date of REC Opinion
8 Jul 2020
REC opinion
Further Information Favourable Opinion